What was once a war on drugs has turned into a public push for the decriminalization and legalization of illegal drugs with potential therapeutic benefits. Legalization efforts began with marijuana in 2018, creating a booming market for investors. Now, the psychedelics market is in the spotlight, with states across America looking to decriminalize psychedelic mushrooms. California is the latest state inching closer to decriminalizing shrooms, with a third city now pushing for legalization thanks to ongoing research into the benefits of psychedelics in the treatment and management of mental illnesses. Investors are taking note of these developments, creating an exciting opportunity for companies like Numinus Wellness Inc. (TSXV:NUMI) (OTC:LKYSF), Mind Medicine (MindMed) Inc. (NASDAQ:MNMD) (NEO:MMED), Cybin Inc. (NEO:CYBN), COMPASS Pathways plc. (NASDAQ:CMPS), and Atai Life Sciences N.V. (NASDAQ:ATAI).
Numinus Takes Steps to Position Itself as a Leader in the Psychedelic Market
Numinus Wellness Inc. (TSXV:NUMI) (OTC:LKYSF) is a mental health and wellness company dedicated to providing access to safe and evidence-based psychedelic therapies that aim to heal rather than manage symptoms of depression, anxiety, trauma, substance abuse, and pain. As the first Canadian public company to receive a dealer’s license from Health Canada to produce and extract psilocybin from mushrooms and the first to complete a legal harvest of psilocybe mushrooms, Numinus Wellness Inc. is positioned at the forefront of the psychedelic medicine movement.
On July 12, 2021, Numinus Wellness announced that Health Canada has given the green light to the MAPS-sponsored open-label study evaluating MDMA-assisted therapy for post-traumatic stress disorder (PTSD). The study is being pursued in collaboration with a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), the leading developer of MDMA-assisted therapy training programs, treatment protocols, and research. Study preparations are now transitioning into the final stages of training staff, importing medication and obtaining ethical approval to allow the recruitment of participants. This study advanced through the pre-implementation stage at Numinus’ Vancouver clinic and has now received the required federal regulatory approval.
“We are thrilled that Health Canada has issued its No Objection Letter allowing this important study to proceed and, in doing so, potentially advance Canada toward a legal, regulated system for MDMA-assisted therapy,” said Numinus CEO Payton Nyquvest. “At Numinus, we are focused on expanding patient access to psychedelic-assisted therapies such as MDMA for PTSD, and we are gratified that our study will provide safety and outcome data to regulators to support integration of this treatment into mainstream mental health care.”
Days earlier, Numinus announced the acquisition of the Neurology Centre of Toronto (NCT), a fully operational neurology centre with 13 doctors, 8 allied health staff, nurse practitioners and physician assistants. NCT’s expertise in clinical neurology and associated mental health disorders will be integrated with Numinus’ leadership in psychedelic-assisted psychotherapy to establish the field of psychedelic neurology, to develop strategies and treatments for those with select neurological and concurrent disorders. The acquisition of this revenue-generating centre offers Numinus additional expertise and access to NCT’s information technology-based virtual rapid access care model, which will help streamline and scale pathways for patients to access psychedelic-assisted psychotherapies.
Numinus Wellness Inc. also recently received amendments to its federal license to allow the possession, production, assembly, sale, export, and delivery of several psychedelics including ketamine and Lysergic acid diethylamide (LSD). The company also closed an impressive upsized $40 million bought deal financing and announced its plans to expand its state-of-the-art psychedelics research laboratory, which will be equipped with $1.2 million in new equipment.
Numinus Wellness closed the second quarter with $65 million in cash, providing the company with the capital to bolster its leadership team, file a patent application with the United States Patent and Trademark Office for a process that dramatically increases the production of therapeutics for use in psychedelic-assisted psychotherapy, and launch a Phase 1 clinical trial of natural psilocybin mushroom extraction in partnership with KGK Science.
These Companies are Seeking to Transform Mental Health with Psychedelic Therapies
Mind Medicine (MindMed) Inc. (NASDAQ:MNMD) (NEO:MMED) is a clinical-stage psychedelic medicine biotech company that develops psychedelic medicines and therapies for the treatment of mental illness and addiction. The company recently received Type C meeting responses from the FDA regarding its Project Lucy. Afterward, the company intends to submit its IND in Q3 and begins the phase 2b clinical trials in Q4 2021. Mind Medicine is also collaborating with Nextage Therapeutics in a program to optimize the delivery of psychedelic drug candidates using the Brain Targeting Liposome System to mitigate some serious side effects that come with orally administered psychedelics. The company also collaborated with Swiss lab Liechti Lab in the publication of the first pharmacogenetic data on LSD to help in dose selection based on individual factors.
Cybin Inc. (NEO:CYBN) is another company active in the psychedelic space. The biotechnology company focused on developing psychedelic therapies announced that its wholly-owned subsidiary Adelia Therapeutics Inc. achieved part of its earn-out milestones after positive pre-clinical results. The completion of these milestones advances the company’s portfolio of differentiated psychedelic-based therapies for different mental health conditions. Cybin also released its financial results for the FY ended March 31, 2021, which show cash and cash equivalents of C$64,026,000 as of March 31, 2021. The company boasts an expanded IP portfolio with 12 patent filings, including an international patent application, which gives Cybin potential patent coverage in 153 counties.
COMPASS Pathways plc. (NASDAQ:CMPS) is another company positioned to benefit from the boom in the psychedelics market space. COMPASS recently completed the administration to a target of 216 patients in a phase 2b clinical trial. The study is investigating the safety and efficacy of psilocybin therapy by comparing 25 mg and 10 mg of COMP360 psilocybin with 1 mg administered together with psychological support from trained therapists. Compass Pathways expects to finalize all psilocybin sessions by July 8, with the report data expected sometime in late 2021. COMP360, if approved, could receive up to 11 years of market exclusivity in the EU and US.
Atai Life Sciences (NASDAQ:ATAI) is another clinical-stage biopharmaceutical company that seeks to transform the treatment of mental health conditions using innovative psychedelic-based drugs. The company became the latest psychedelic company to go public, launching its IPO of 14,286,000 of its common shares on June 11, 2021, with the expected price of between $13 and $15 per common share. The company later upsized its IPO on June 17, 2021, offering 15,000,000 in the US for $15 per share.
Psychedelics are gaining mainstream acceptance as researchers, patients, and investors take note of their medical benefits. Companies like Numinus Wellness Inc. (TSXV:NUMI) (OTC:LKYSF) are positioning themselves for this market opportunity.
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